Acknowledgements

The PIPA Committee would like to thank the following members of the PIPA Training Working Party who played a major role in the development of this course:

  • Shirley-Ann Van Der Spuy, Qualified Person for Pharmacovigilance (QPPV) at Red Line Pharmacovigilance Ltd.
  • Esther Straghan, Associate Safety Risk Lead, Pfizer Ltd.
  • Manju Bhandari, Medical Information, Astellas Pharma Ltd.
  • Sarah Hall, Mipsol Ltd.
  • Cecilia Adetola, Medical Signatory Pharmacist, CK Management Ltd
  • Sharon Braithwaite, PIPA Membership & Events Coordinator
  • Anne Turnbull, PIPA Operations Manager

Subcontracting

  • Marketing authorisation holders may subcontract certain PV activities including the role of the QPPV.
  • The MAH retains full responsibility for all PV activities even if they are outsourced and for any updates to and confirmation of accuracy of the PSMF.
When subcontracting tasks:
  • Contracts should be in place to clearly document contractual arrangements between the marketing authorisation holder and the other organisation, describing arrangements for delegation and the responsibilities of each party.
  • A description of the subcontracted activities and/or services must be added to the PSMF.
  • An annex to the PSMF must include a list of all subcontracts, specifying the product(s) and territory(ies) concerned.

Retention Period

During Retention Period, ensure retrievability of documents:
  • Electronic format – Documents can be retained in electronic format if system is validated, secure, backed-up and documents can be accessed.
  • If paper documents are transferred into an electronic format all information on the paper documents must be retained in a legible manner and the media used for storage must remain readable over time.
  • If the business of the marketing authorisation holder is taken over by another organisation all PV relevant documentation must be transferred.

Quality system processes

The MAH should have processes to ensure:
  • Submission of adverse reaction data to EudraVigilance within the legal timelines.
  • Regular review to ensure use of appropriate terminology (such as MedDRA).
  • Retention of minimum elements of the PSMF whilst the PV system exists and for at least 5 years after it has been formally terminated.
  • Retention of pharmacovigilance data and documents relating to individual authorised medicinal products whilst the marketing authorisation exists and for at least 10 years after the marketing authorisation has ceased to exist.
  • Product information is kept up-to-date by the marketing authorisation holder in the light of scientific knowledge and any assessments and recommendations made public via the European medicines web-portal. This includes a requirement to monitor the information made public on the European medicines web-portal.

Retention periods above apply unless the documents shall be retained for a longer period where EU or national law so requires.

Delegation

  • The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals provided that the QPPV maintains system oversight and overview of the safety profiles of all products.
  • Such delegation should be documented.

EU QPPV responsibilities

In relation to the medicinal product the EU QPPV should:

  • Have an overview of medicinal product safety profiles and any emerging safety concerns.
  • Have awareness of any MAH conditions, obligations and commitments relating to the products.
  • Have awareness of risk minimisation measures.
  • Be aware of and have sufficient authority over the content of risk management plans.
  • Be involved in review and sign-off of protocols of post-authorisation safety studies conducted in the EU including those which are part of a risk management plan.
  • Have awareness of post-authorisation safety studies requested by a competent authority including the results of such studies.
  • Ensure conduct of pharmacovigilance according to legal requirements and GVP.
  • Ensure the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency.
  • Ensure full, prompt responses to requests from competent authorities in Members States and the European Medicines Agency.
  • Provide any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the European Medicines Agency.
  • Provide input into regulatory action in response to emerging safety concerns, such as variations, urgent safety restrictions, and communication to patients and healthcare professionals).
  • Act as a single pharmacovigilance contact point, on a 24-hour basis, for the competent authorities in Member States and the European Medicines Agency and for pharmacovigilance inspections.

Role of the QPPV

  • The QPPV is a person (not a group).
  • QPPV is appropriately qualified and continuously at the disposal of the MAH.
  • Shall reside in the EU (or Norway, Iceland, Lichtenstein).
  • Back-up procedures should be in place (the back up person should have all necessary information to fulfil the role).
  • Is responsible for establishing and maintaining the MAH PV system and is able to influence the performance of the quality system and PV activities to meet EU obligations.
  • Has access to the PSMF and authority to verify the info contained therein to ensure it is an accurate and up to date reflection of the PV system.

QPPV Qualifications

MAH must ensure that:

  1. QPPV has adequate theoretical and practical knowledge for the performance of pharmacovigilance activities.
  2.  Should have skills for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences, epidemiology and biostatistics.
  3. If the QPPV is not medically trained they must be assisted by a medically trained person and the assistance must be documented (Article 24 of Directive 2005/36/EC).

Expanding – acquisitions and partnerships

Acquisitions

  • EU QPPV should be notified as early as possible in the due diligence process so they can assess potential impact on and any changes need to the pharmacovigilance system. Including PV data that needs to be transferred and PV responsibilities in the contract pre- and post-acquisition.

Partnerships with MAH/organisations or persons impacting PV

  • EU QPPV should be informed early enough and be involved in the preparation of the contract to ensure that all necessary provisions relevant to the pharmacovigilance system are included.

Adverse reaction database

  • Ensure the EU QPPV is able to obtain information from the database, for example, to respond to urgent requests for information from the competent authorities or the European Medicines Agency, at any time (Detail this in a procedure).
  • If this procedure requires the involvement of other personnel, for example database specialists, then take this into account in the arrangements for supporting the EU QPPV outside of normal working hours.
  • The EU QPPV must be aware of the validation status of the database including any validation failures and how these have been addressed.
  • The EU QPPV must be made aware of significant changes to the database – since they may impact PV activities.